RecruitingNot ApplicableNCT06497569

Support Through Remote Observation and Nutrition Guidance Program for Individuals With Gastroesophageal Cancer

Support Through Remote Observation and Nutrition Guidance Program for Individuals With Gastroesophageal Cancer (STRONG-GEC)


Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Enrollment

80 participants

Start Date

Jul 26, 2024

Study Type

INTERVENTIONAL

Summary

The purpose of this study is to determine how the STRONG intervention compares with usual care for reducing malnutrition among gastroesophageal cancer patients.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • Participants must be 18 years of age or older
  • Participants must have locally advanced or metastatic gastroesophageal cancer (GEC)
  • Participants must plan to initiate chemotherapy and/or radiation therapy with a plan to have surgery or definitive treatment follow up at Moffitt
  • Participants must be able to speak and read Spanish and/or English
  • Participants must be able to provide informed consent

Exclusion Criteria2

  • Participants have a documented or observable psychiatric or neurological disorder that would interfere with study participation (e.g. severe dementia)
  • Use of feeding tubes at the time of study enrollment

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Interventions

BEHAVIORALDietitian Consultation

Participants will meet with a dietitian who will provide individualized nutrition counseling and dietary goals for calorie and protein intake. Bi-weekly, 30-minute dietitian telehealth visits will be conducted via ZOOM videoconferencing at the pre-intervention baseline visit, monthly during the intervention period (up to 90 days) and at the 4 and 6 month timepoints post-intervention.

BEHAVIORALSurvey

Surveys will be conducted using the PG-SGA short form19-21 and a brief symptom assessment tool that captures additional nutrition-impact symptoms not captured by the PG-SGA (e.g., swallowing difficulty) measured by the FACT Esophageal and Gastric Cancer scales and the FAACT anorexia/cachexia scales 22,23 through REDCap. Surveys are completed at the pre-intervention baseline visit and monthly during the intervention period prior to the dietitian visits (up to 90 days), and at the 4 and 6 month timepoints post-intervention.

BEHAVIORALFitbit Data Collection

Participants will log food intake while sharing their data with a dietitian during the 30-minute dietitian telehealth visits at the pre-intervention baseline visit, monthly during the intervention period (up to 90 days) and at the 4 and 6 month timepoints post-intervention.

BEHAVIORALReferral to Dietitian

Usual Care condition referral to a dietitian based on physician discretion.

BEHAVIORALSocial Determinants of Health Survey (SDOH)

Participants will complete a SDOH Survey that captures individual-level factors (insurance type, preferred language, educational attainment, annual household income, digital health literacy, financial toxicity, and self-reported barriers to care \[e.g., transportation\]) and structural-level factors (neighborhood disadvantage, rural residence). Digital health literacy will be measured using the validated eHEALS scale, an 8-item measure assessing confidence with finding, evaluating, and applying electronic information to inform health decision-making (score ≤ 30 indicates low literacy).


Locations(2)

Moffitt Cancer Center

Tampa, Florida, United States

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States

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NCT06497569